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Sphingosine-1-Phosphate Receptor Modulator

Etrasimod for Eczema

Phase 2 & 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic AD (also known as atopic eczema) that was diagnosed at least 1 year prior to Screening and meets Hanifin and Rajka criteria at screening
Moderate to severe AD: IGA score ≥3 at screening and baseline, BSA ≥10% of AD involvement at screening and baseline, Eczema Area and Severity Index (EASI) ≥16 at screening and baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 68 weeks in part 1 and up to 52 weeks in part 2
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of etrasimod, a pill taken once daily, to treat moderate-to-severe atopic dermatitis (eczema) in adults who tried treatments that work all over the body and saw no effects. Participants will visit the clinic 6-12 times over 16-68 weeks, with tests for signs/symptoms, blood samples and vital signs.

Who is the study for?
Adults aged 18-80 with moderate to severe atopic dermatitis (AD), also known as eczema, who have not seen improvement after trying systemic therapies. Participants must have had AD for at least a year and be willing to use daily moisturizers throughout the study.Check my eligibility
What is being tested?
The trial is testing Etrasimod, an oral medication, against a placebo in adults with AD. Part 1 randomly assigns participants to either drug or placebo for 16 weeks; some may continue Etrasimod for another 52 weeks. Part 2 involves all participants taking Etrasimod for one year.See study design
What are the potential side effects?
Potential side effects of Etrasimod include reactions related to immune system changes since it affects how certain cells work in the body. This could lead to increased risk of infections or other immune-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with chronic eczema for over a year.
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My eczema is moderate to severe, covering more than 10% of my body.
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I have tried a treatment for my condition before and it didn't work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 68 weeks in part 1 and up to 52 weeks in part 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 68 weeks in part 1 and up to 52 weeks in part 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 DB: Proportion of participants achieving IGA of clear (0) or almost clear (1) (on a 5-point scale) and a reduction of ≥ 2 points from baseline
Part 1 OLE and Part 2: Incidence and severity of treatment-emergent adverse events (AEs), AEs leading to study treatment discontinuation, serious AEs, and AEs of special interest.
Part 1 OLE and Part 2: Incidence of clinically significant changes in AP, ALT (SGPT), AST (SGOT) (U/L)
+18 more
Secondary outcome measures
Part 1 DB: Percent change from baseline in EASI
Part 1 DB: Proportion of participants achieving a EASI-75

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: etrasimodExperimental Treatment1 Intervention
2 mg, oral tablet, once daily
Group II: Placebo (Part 1 DB period only)Placebo Group1 Intervention
Oral sham comparator

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Atopic Dermatitis (AD) include topical corticosteroids, calcineurin inhibitors, and systemic immunomodulators. Topical corticosteroids reduce inflammation by inhibiting multiple inflammatory cytokines, providing quick relief from itching and redness. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, block T-cell activation, reducing immune responses that cause skin inflammation. Systemic treatments like dupilumab, a monoclonal antibody, target specific pathways like the IL-4 and IL-13 signaling, crucial in the inflammatory process of AD. Etrasimod, an S1P receptor modulator, works by modulating immune cell trafficking, potentially reducing inflammation and immune response. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the severity and specific characteristics of the patient's AD.

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,587 Previous Clinical Trials
14,637,824 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,491 Previous Clinical Trials
11,814,576 Total Patients Enrolled

Media Library

Etrasimod (Sphingosine-1-Phosphate Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05732454 — Phase 2 & 3
Atopic Dermatitis Research Study Groups: etrasimod, Placebo (Part 1 DB period only)
Atopic Dermatitis Clinical Trial 2023: Etrasimod Highlights & Side Effects. Trial Name: NCT05732454 — Phase 2 & 3
Etrasimod (Sphingosine-1-Phosphate Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05732454 — Phase 2 & 3
Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT05732454 — Phase 2 & 3
~24 spots leftby Jun 2025